Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)
Trial Parameters
Brief Summary
This study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help transplant recipients with a high risk for developing late CMV disease after a liver and/or kidney transplant.
Eligibility Criteria
Inclusion Criteria * High risk pretransplant CMV donor seropositive/recipient seronegative (D+R-) kidney, liver, or simultaneous liver-kidney (SLK) transplant recipients * Able to do routine blood testing (normal care for transplant recipients) * Written informed consent obtained from the subject before any trial-related procedures * Be ≥18 years and ≤75 years of age at time of consent Exclusion Criteria * Any pre-transplant CMV serologic combinations besides CMV D+/R- * Multi organ transplants (other than simultaneous liver-kidney transplant (SLK) recipients) or prior history of bone marrow or stem cell transplant * Lung, heart, small bowel, pancreas, or other non-kidney or non-liver transplant recipients * Transplant recipients treated for rejection within three months before the end of valganciclovir prophylaxis * Participation in another interventional clinical trial at time of consent or within 30 days prior to study consent * Transplant recipients with eGFR \<30 ml/min/1.73m2 (as